Insulin Glargine in Type 1 Diabetes Mellitus: A Review of Clinical Trials and Real-world Evidence Across Two Decades.

BACKGROUND: Over the past two decades, insulin glargine 100 U/mL (Gla-100) has emerged as the "standard of care" basal insulin for the management of type 1 diabetes mellitus (T1DM). Both formulations, insulin glargine 100 U/mL (Gla-100) and glargine 300 U/mL (Gla- 300) have been extensively studied against various comparator basal insulins across various clinical and real-world studies. In this comprehensive article, we reviewed the evidence on both insulin glargine formulations in T1DM across clinical trials and real-world studies. METHODS: Evidence in T1DM for Gla-100 and Gla-300 since their approvals in 2000 and 2015, respectively, were reviewed. RESULTS: Gla-100 when compared to the second-generation basal insulins, Gla-300 and IDeg-100, demonstrated a comparable risk of overall hypoglycemia, but the risk of nocturnal hypoglycemia was higher with Gla-100. Additional benefits of Gla-300 over Gla-100 include a prolonged (>24- hours) duration of action, a more stable glucose-lowering profile, improved treatment satisfaction, and greater flexibility in the dose administration timing. CONCLUSION: Both glargine formulations are largely comparable to other basal insulins in terms of glucose-lowering properties in T1DM. Further, risk of hypoglycemia is lower with Gla-100 than Neutral Protamine Hagedorn but comparable to insulin detemir.

Addendum 1: Forum for Injection Technique and Therapy Expert Recommendations, India.

With the emerging complexities in chronic diseases and people's lifestyles, healthcare professionals (HCPs) need to update their methods to manage and educate patients with chronic lifestyle disorders, particularly diabetes. The insulin injection technique (IIT), along with various parameters, must also be updated with newer methods. Forum for Injection Technique and Therapy Expert Recommendations (FITTER), India, has updated its recommendations to cover newer ways of detecting hypoglycaemia and lipohypertrophy, preventing needlestick injuries (NSIs), discouraging the reuse of insulin needles and encouraging good disposal. FITTER, India, is also introducing recommendations to calculate insulin bolus dose. These updated recommendations will help HCPs better manage patients with diabetes and achieve improved outcomes.

Indian Reality of Clinical Practice and Patient Profile in Diabetes Care: Lessons from the IMPACT survey.

India shoulders a heavy burden of diabetes mellitus (DM), the management of which is suboptimal globally.& Objectives: Insulin Management: Practical Aspects in Choice of Therapy (IMPACT) survey was designed to gain insight into the ground (in-clinic) reality of DM management by physicians in India. METHODS: A survey consisting of 12 multiple-choice questions was conducted by SurveyMonkey® , focusing on practice profile, patient profile, and other aspects of DM management. RESULTS: The survey included 2424 physicians. Majority of them were general physicians (58.5%) followed by diabetologists (31.1%). Most (49.2%) of the respondents specified that the ideal time for a DM consultation is 15 min. However, 73.4% of them provided consultation of <10& min because of heavy patient load. Nearly half of the respondents reported that their patients consumed a diet with carbohydrate content of 60% to 80%, and 79.4% of them admitted that <50% of their patients adhered to dietary advice. About 73.5% of the respondents believed controlling fasting plasma glucose (FPG) level alone would not adequately control postprandial plasma glucose (PPG) level, and 93.0% of them preferred an insulin therapy at the initiation that controls both FPG and PPG levels. CONCLUSION: Limited consultation time, high-carbohydrate diet, and a need for choosing insulin regimens that provide control for both PPG and FPG levels are some ground realities of DM management in India. These realities need to be factored in while choosing treatment options to achieve the desired glycemic control and improve the status of diabetes care.

Forum for Injection Technique and Therapy Expert Recommendations, India: The Indian Recommendations for Best Practice in Insulin Injection Technique, 2017.

Health-care professionals in India frequently manage injection or infusion therapies in persons with diabetes (PWD). Patients taking insulin should know the importance of proper needle size, correct injection process, complication avoidance, and all other aspects of injection technique from the first visit onward. To assist health-care practitioners in their clinical practice, Forum for Injection Technique and Therapy Expert Recommendations, India, has updated the practical advice and made it more comprehensive evidence-based best practice information. Adherence to these updated recommendations, learning, and translating them into clinical practice should lead to effective therapies, improved outcomes, and lower costs for PWD.

Forum for Injection Technique 2.0 Addendum 1: Insulin use in indoor settings.

Insulin is a frequently used drug in the indoor setting. Comprehensive recommendations for best practice in insulin injection technique have been published by the forum for injection technique (FIT), India. This addendum focuses on insulin use in indoor settings, and complements the FIT 2.0 recommendations. It discusses insulin use and disposal in critical care and noncritical care settings. It also highlights the need to ensure continuing nursing and medical education, and frame insulin policies for such use.

Forum for Injection Technique (FIT), India: The Indian recommendations 2.0, for best practice in Insulin Injection Technique, 2015.

As injectable therapies such as human insulin, insulin analogs, and glucagon-like peptide-1 receptor agonists are used to manage diabetes, correct injection technique is vital for the achievement of glycemic control. The forum for injection technique India acknowledged this need for the first time in India and worked to develop evidence-based recommendations on insulin injection technique, to assist healthcare practitioners in their clinical practice.

Forum for injection techniques, India: the first Indian recommendations for best practice in insulin injection technique.

Advances in the treatment of diabetes have led to an increase in the number of injectable therapies, such as human insulin, insulin analogues, and glucagon-like peptide-1 analogues. The efficacy of injection therapy in diabetes depends on correct injection technique, among many other factors. Good injection technique is vital in achieving glycemic control and thus preventing complications of diabetes. From the patients' and health-care providers' perspective, it is essential to have guidelines to understand injections and injection techniques. The abridged version of the First Indian Insulin Injection technique guidelines developed by the Forum for Injection Technique (FIT) India presented here acknowledge good insulin injection techniques and provide evidence-based recommendations to assist diabetes care providers in improving their clinical practice.

Consensus dietary guidelines for healthy living and prevention of obesity, the metabolic syndrome, diabetes, and related disorders in Asian Indians.

India is undergoing rapid nutritional transition, resulting in excess consumption of calories, saturated fats, trans fatty acids, simple sugars, salt and low intake of fiber. Such dietary transition and a sedentary lifestyle have led to an increase in obesity and diet-related non-communicable diseases (type 2 diabetes mellitus [T2DM], cardiovascular disease [CVD], etc.) predominantly in urban, but also in rural areas. In comparison with the previous guidelines, these consensus dietary guidelines include reduction in the intake of carbohydrates, preferential intake of complex carbohydrates and low glycemic index foods, higher intake of fiber, lower intake of saturated fats, optimal ratio of essential fatty acids, reduction in trans fatty acids, slightly higher protein intake, lower intake of salt, and restricted intake of sugar. While these guidelines are applicable to Asian Indians in any geographical setting, they are particularly applicable to those residing in urban and in semi-urban areas. Proper application of these guidelines will help curb the rising "epidemics" of obesity, the metabolic syndrome, hypertension, T2DM, and CVD in Asian Indians.

Weight gain in type 2 diabetics with different treatment modalities.

BACKGROUND: The aim of this study was to study (1) weight gain in type 2 diabetics with different treatment modalities and (2) relationship of weight gain with stable adult weight. METHODS: A study of 469 type 2 diabetics on regular follow-up was undertaken to determine the effect of modality of therapy on patient's weight. Stable weight maintained by the patient in good health was ascertained. Weight at visit 1 and subsequently at every follow-up was noted. Patients were grouped as per treatment modality. Weight gain was correlated with pretreatment weight loss, stable weight, and degree of metabolic control. RESULTS: All treatment subgroups showed a steady upward trend of weight gain at 1-year follow-up. Maximum weight gain was seen in the sulphonylurea and insulin (SU + I) group (mean +/- SD, kg; 2.9 +/- 3.8, p < 0.05) followed by the insulin group (1.8 +/- 4.9), SU group (1.2 +/- 2.9), and SU + metformin (MF) + I group (0.6 +/- 2.8), and was the least in the SU + MF group (0.6 +/- 2.9). Weight gain was not significant, except in SU + I group. Addition of metformin prevented weight gain until 9 months follow-up, but the trend reversed on prolonged follow-up. Most patients tended to move towards their stable body weight. Patients with weight loss in the pre-treatment period (n = 253; weight loss 4.1 +/- 1.6 kg) gained significant weight (4.5 +/- 1.9 kg), while those without significant weight loss in the pre-treatment period (n = 216) did not. Weight gain was significant in the good and fair glycemic control groups, but not so in the poor glycemic control group. CONCLUSIONS: Only the SU + I group gained significant weight. The weight gain on treatment was significantly related to pre-treatment weight loss. Most patients moved towards their stable body weight with improved metabolic control.